Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
40–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Men or women who are between 40 and 75 years of age
Female subjects must be of non-childbearing
Subject diagnosed with COPD
Body Mass Index 18.0 - 32.0 kg/m2 (inclusive)
Subject is a smoker or an ex-smoker
Subject has post-bronchodilator (200µg salbutamol) FEV1 of = 40% to = 80% of predicted normal.
Subject has FEV1/FVC \< 0.7 post-bronchodilator (200µg salbutamol).
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Subject is available to complete all study measurements and procedures.
Subjects have a 24hour holter recording that is within normal limits and does not demonstrate any clinically important abnormality that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
You may not be if
Subjects who have a past or present disease, which as judged by the Investigator and the Medical Monitor, may affect the outcome of this study.
The subject has a positive pre-study alcohol screen.
The subject has a positive pre-study drug screen.
History of alcohol/drug abuse or dependence within 12 months of the study: Abuse
The subject has a positive pregnancy test.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Subject has tested positive for HIV
The subject has participated in a clinical trial and has received a drug or a new chemical entity within 60 days or 5 half-lives
Exposure to more than three new chemical entities (NCE) within 10 months prior to the first dosing day or one NCE within 3 months prior to the first dosing day.
The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study.
The subject has a known allergy or hypersensitivity to ipratropium bromide, atropine and any of its derivatives or milk protein/lactose.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
Subject has prostate hypertrophy or narrow angle glaucoma
Clareo Health | A Dose Ascending, Study To Examine The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of GSK233705B.
